UMIN-CTR Clinical Trial

Basic information
Public title	The effect of 12-week intake of NMN on the sleep and fatigue of community-dwelling older adults
Acronym	The effect of NMN intake on sleep and fatigue
Scientific Title	The effect of 12-week intake of NMN on the sleep and fatigue of community-dwelling older adults
Scientific Title:Acronym	The effect of NMN intake on sleep and fatigue
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of daily intake of NMN for 12 weeks on sleep, fatigue and mental health with community-dwelling older adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of Pittsburgh Sleep Quality Index(PSQI), Visual Analogue Scale(VAS) of evaluating physical fatigue and eye strain, Geriatric depression scale(GDS), Sense of Coherence(SOC) using questionnaires
Key secondary outcomes	1) Physical performance tests: Grip strength, Five times sit to stand, Timed up and go, 5m habitual walk 2) Cognitive functions: Trail Making Peg, Five cognitive function test(attention, verbal memory, visuospatial cognition, word fluency, associate learning)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of NMN (253.8mg) every morning for 12 weeks (from getting up to 12 am)
Interventions/Control_2	Intake of NMN (253.8mg) every afternoon for 12 weeks (from getting up to 12 am (from 6pm to before bedtime)
Interventions/Control_3	Intake of placebo every morning for 12 weeks (from getting up to 12 am)
Interventions/Control_4	Intake of placebo every afternoon for 12 weeks (from 6pm to before bedtime)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects with the capacity to participate the study-related briefing sessions, examinations and measurements in University of Tsukuba by themselves 2) Subjects without dementia, need for long-term care service, sleep disorders or regular intake of sleeping drugs(more than once a week) depression or regular intake of anti-depressants(more than once a week) 3) Subjects with a thorough understanding of this study, and voluntary consent
Key exclusion criteria	1) Subjects with a regular intake of sleeping drugs or anti-depressants(more than once a week) 2) Subjects with an average intake of caffeine more than 400mg per day 3) Subjects with intake of supplements, nutrition drinks or energy drinks that contain NMN or niacin (Vitamin B3, nicotinamide, nicotinic acid amide) 4) Subjects with allergies to supplements, nutrition drinks or energy drinks that contain NMN or niacin(Vitamin B3, nicotinamide, nicotinic acid amide) 5) Subjects diagnosed with chronic fatigue syndrome, sleep disorders(insomnia), mental disorders such as depression, or alcoholism and under medical treatment 6) Subjects who correspond to Not at all in category of fatigue, poor sleep or stress based on 5 level evaluation (Not at all, Slightly, Moderately, Very much, Extremely) 7) Subjects who are involving in other clinical experiments currently or having participated any other clinical experiments in the past 3 months 8) Subjects excluded as inappropriate participants by the lead principal investigator
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Okura
Organization	University of Tsukuba
Division name	Faculty of Health and sport science
Zip code	305-8574
Address	1-1-1 Tennodai, Tsukuba
TEL	029-859-2733
Email	okura.tomohiro.gp@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name Mijin Middle name Last name Kim
Organization	University of Tsukuba
Division name	Industry-University Collaboration R&D Center for Tailor-Made QOL
Zip code	305-8574
Address	1-1-1 Tennodai, Tsukuba
TEL	029-859-2744
Homepage URL
Email	mjmj0816@gmail.com

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Tsukuba
Address	1-1-1 Tennodai, Tsukuba
Tel	029-853-2571
Email	takano.nobuo.ka@un.tsukuba.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	108
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 05 Month 15 Day
Date of IRB	2019 Year 07 Month 23 Day
Anticipated trial start date	2019 Year 08 Month 28 Day
Last follow-up date	2019 Year 11 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 25 Day
Last modified on	2020 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043422